Commission Directive 2008/44/EC of 4 April 2008 amending Council Directive 91/414/EEC to include benthiavalicarb, boscalid, carvone, fluoxastrobin, Paecilomyces lilacinus and prothioconazole as active substances (Text with EEA relevance)

• CELEX: Directive 2008/44/EC
• Articles: 6

Article 1

Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive.

Article 2

1.   Member States shall adopt and publish by 31 January 2009 at the latest the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.

They shall apply those provisions from 1 February 2009.

When Member States adopt those provisions, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.

2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.

Article 3

1.   Member States shall in accordance with Directive 91/414/EEC, where necessary, amend or withdraw existing authorisations for plant protection products containing benthiavalicarb, boscalid, carvone, fluoxastrobin, Paecilomyces lilacinus or prothioconazole as active substance by 31 January 2009. By that date, they shall in particular verify that the conditions in Annex I to that Directive relating to benthiavalicarb, boscalid, carvone, fluoxastrobin, Paecilomyces lilacinus or prothioconazole, respectively, are met, with the exception of those identified in part B of the entry concerning the active substance, and that the holder of the authorisation has, or has access to, a dossier satisfying the requirements of Annex II to that Directive in accordance with the conditions of Article 13(2) of that Directive.

2.   By way of derogation from paragraph 1, for each authorised plant protection product containing benthiavalicarb, boscalid, carvone, fluoxastrobin, Paecilomyces lilacinus or prothioconazole as either the only active substance or as one of several active substances all of which were listed in Annex I to Directive 91/414/EEC by 31 July 2008 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles provided for in Annex VI to Directive 91/414/EEC, on the basis of a dossier satisfying the requirements of Annex III to that Directive and taking into account part B of the entry in Annex I to that Directive concerning benthiavalicarb, boscalid, carvone, fluoxastrobin, Paecilomyces lilacinus or prothioconazole. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 4(1)(b), (c), (d) and (e) of Directive 91/414/EEC.

Following that determination Member States shall:

(a)

in the case of a product containing benthiavalicarb, boscalid, carvone, fluoxastrobin, Paecilomyces lilacinus or prothioconazole as the only active substance, where necessary, amend or withdraw the authorisation by 31 January 2010 at the latest; or

(b)

in the case of a product containing benthiavalicarb, boscalid, carvone, fluoxastrobin, Paecilomyces lilacinus or prothioconazole as one of several active substances, where necessary, amend or withdraw the authorisation by 31 January 2010 or by the date fixed for such an amendment or withdrawal in the respective Directive or Directives which added the relevant substance or substances to Annex I to Directive 91/414/EEC, whichever is the latest.

Article 4

This Directive shall enter into force on 1 August 2008.

Article 5

This Directive is addressed to the Member States.

Schedules & Appendices

ANNEX

ANNEX

In Annex I to Directive 91/414/EEC, the following rows are added at the end of the table:

No

Common name, identification numbers

IUPAC name

Purity  ( *1 )

Entry into force

Expiration of inclusion

Specific provisions

‘169

Benthiavalicarb

CAS No 413615-35-7

CIPAC No 744

[(S)-1-{[(R)-1-(6-fluoro-1,3-benzothiazol-2-yl)ethyl]carbamoyl}-2-methylpropyl]carbamic acid

≥ 910 g/kg

The following manufacturing impurities are of toxicological concern and each of them must not exceed a certain amount in the technical material:

6,6′-difluoro-2,2′-dibenzothiazole: < 3,5 mg/kg

bis(2-amino-5-fluorophenyl) disulfide: < 14 mg/kg

1 August 2008

31 July 2018

Part A

Only uses as fungicide may be authorised.

Part B

For the implementation of the uniform principles of Annex VI, the conclusions of the review report on benthiavalicarb, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

—

the operator safety,

—

the protection of non-target arthropods.

Conditions of use shall include adequate risk mitigation measures, where appropriate.

In assessing applications to authorise plant protection products containing benthiavalicarb for uses other than in glasshouses, Member States shall pay particular attention to the criteria in Article 4(1)(b), and shall ensure that any necessary data and information is provided before such an authorisation is granted.

The Member States shall inform the Commission in accordance with Article 13(5) on the specification of the technical material as commercially manufactured.

170

Boscalid

CAS No 188425-85-6

CIPAC No 673

2-Chloro- N -(4′-chlorobiphenyl-2-yl)nicotinamide

≥ 960 g/kg

1 August 2008

31 July 2018

Part A

Only uses as fungicide may be authorised.

Part B

For the implementation of the uniform principles of Annex VI, the conclusions of the review report on boscalid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention

—

to the operator safety,

—

to the long term risk to birds and soil organisms,

—

to the risk of accumulation in soil if the substance is used in perennial crops or in succeeding crops in crop rotation.

Conditions of use shall include adequate risk mitigation measures, where appropriate.

171

Carvone

CAS No 99-49-0 (d/l mixture)

CIPAC No 602

5-isopropenyl-2-methylcyclohex-2-en-1-one

≥ 930 g/kg with a d/l ratio of at least 100:1

1 August 2008

31 July 2018

Part A

Only uses as plant growth regulator may be authorised.

Part B

For the implementation of the uniform principles of Annex VI, the conclusions of the review report on carvone, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention to the operator safety.

Conditions of use shall include risk mitigation measures, where appropriate.

172

Fluoxastrobin

CAS No 361377-29-9

CIPAC No 746

( E )-{2-[6-(2-chlorophenoxy)-5-fluoropyrimidin-4-yloxy]phenyl}(5,6-dihydro-1,4,2-dioxazin-3-yl)methanone O -methyloxime

≥ 940 g/kg

1 August 2008

31 July 2018

Part A

Only uses as fungicide may be authorised.

Part B

For the implementation of the uniform principles of Annex VI, the conclusions of the review report on fluoxastrobin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

—

the operator safety, in particular when handling the undiluted concentrate. Conditions of use shall include adequate protective measures, such as wearing a face shield,

—

the protection of aquatic organisms. Risk mitigation measures such as buffer zones shall be applied, where appropriate,

—

the levels of residues of the metabolites of fluoxastrobin, when straw from treated areas is used as animal feeding stuff. Conditions of use shall include restrictions for feeding to animals, where appropriate,

—

the risk of accumulation in the soil surface, if the substance is used in perennial crops or in succeeding crops in crop rotation.

Conditions of use shall include risk mitigation measures, where appropriate.

The concerned Member States shall request the submission of:

—

data to allow a comprehensive aquatic risk assessment to be made taking into account spray drift, run-off, drainage and the effectiveness of potential risk mitigation measures,

—

data on toxicity of non-rat metabolites if straw from treated areas is to be used as feedstuff.

They shall ensure that the notifier at whose request fluoxastrobin has been included in this Annex provide such studies to the Commission within two years from the entry into force of the Directive of inclusion.

173

Paecilomyces lilacinus (Thom)

Samson 1974 strain 251 (AGAL: No 89/030550)

CIPAC No 753

Not applicable

1 August 2008

31 July 2018

Part A

Only uses as nematicide may be authorised.

Part B

For the implementation of the uniform principles of Annex VI, the conclusions of the review report on Paecilomyces lilacinus , and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

—

the operator safety (although there was no need to set an AOEL, as a general rule, microorganisms should be considered as potential sensitisers),

—

the protection of leaf dwelling non-target arthropods.

Conditions of use shall include risk mitigation measures, where appropriate.

174

Prothioconazole

CAS No 178928-70-6

CIPAC No 745

(RS)-2-[2-(1-chlorocyclopropyl)-3-(2-chlorophenyl)-2-hydroxypropyl]-2,4-dihydro-1,2,4-triazole-3-thione

≥ 970 g/kg

The following manufacturing impurities are of toxicological concern and each of them must not exceed a certain amount in the technical material:

—

Toluene: < 5 g/kg

—

Prothioconazole-desthio (2-(1-chlorocyclopropyl)1-(2-chlorophenyl)-3-(1,2,4-triazol-1-yl)-propan-2-ol): < 0,5 g/kg (LOD)

1 August 2008

31 July 2018

Part A

Only uses as fungicide may be authorised.

Part B

For the implementation of the uniform principles of Annex VI, the conclusions of the review report on prothioconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

—

the operator safety in spray applications. Conditions of use shall include adequate protective measures,

—

the protection of aquatic organisms. Risk mitigation measures such as buffer zones shall be applied, where appropriate,

—

the protection of birds and small mammals. Risk mitigation measures shall be applied, where appropriate.

Conditions of use shall include risk mitigation measures, where appropriate.

The concerned Member States shall request the submission of:

—

information to allow the assessment of consumer exposure to triazole metabolite derivatives in primary crops, rotational crops, and products of animal origin,

—

a comparison of the mode of action of prothioconazole and the triazole metabolite derivatives to allow the assessment of the toxicity resulting from the combined exposure to these compounds,

—

information to further address the long-term risk to granivorous birds and mammals arising from the use of prothioconazole as a seed treatment.

They shall ensure that the notifier at whose request prothioconazole has been included in this Annex provide such studies to the Commission within two years from the entry into force of the Directive of inclusion.’

( *1 )   Further details on identity and specification of active substances are provided in the review report.